CERTIFICATE OF ACCREDITATION
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1 CERTIFICATE OF ACCREDITATION In terms of section 22(2) (b) of the Accreditation for Conformity Assessment, Calibration and Good Laboratory Practice Act, 2006 (Act 19 of 2006), read with sections 23(1), (2) and (3) of the said Act, I hereby certify that:- NATIONAL HEALTH LABORATORY SERVICE (NHLS) UNIVERSITAS ACADEMIC LABORATORY Practice No.: PR CHEMICAL PATHOLOGY LABORATORY Facility Accreditation Number: M0388A is a South African National Accreditation System accredited facility provided that all conditions and requirements are complied with This certificate is valid as per the scope as stated in the accompanying schedule of accreditation, Annexure A, bearing the above accreditation number for MEDICAL TESTING LABORATORY CHEMISTRY, ENDOCRINOLOGY AND SEROLOGY The facility is accredited in accordance with the recognised International Standard ISO 15189:2012 The accreditation demonstrates technical competency for a defined scope and the operation of a quality management system While this certificate remains valid, the accredited facility named above is authorised to use the relevant accreditation symbol to issue facility reports and/or certificates Mr R Josias Chief Executive Officer Effective Date: 01 December 2017 Certificate Expires: 15 October 2021
2 ANNEXURE A SCHEDULE OF ACCREDITATION Facility Number: M0388A Permanent Address of Laboratory: National Health Laboratory Service (NHLS) Signatories: Signatories as authorised by the Head of Laboratory Universitas Laboratory, Dept of Chemical Pathology Block C, Francois Retief Building Nelson Mandela Drive Bloemfontein 9301 Postal Address: P O Box 339 (G3) Contact Person: Mrs I Freitag Bloemfontein 9301 Tel: (051) Issue No.: 07 Fax: (051) Date of Issue: 04 December ina.freitag@nhls.ac.za Expiry Date: 15 October 2021 Discipline / Sample Type Type of Tests Equipment / Method Chemistry Pleural Fluid, Ascitis Fluid, CSF Adenosine Deaminase (ADA) Cobas 6000 Serum, Plasma Alanine Aminotransferase (ALT) Cobas 6000, CSF Albumin Cobas 6000 Urine Albumin (Micro) Cobas 6000 Serum, Plasma Alkaline Phosphatase (ALP) Cobas 6000 Plasma Ammonia Cobas 6000 Serum, Urine Amylase Cobas 6000 Serum, Plasma Aspartate Aminotransferase (AST) Cobas 6000 Serum, Plasma Bicarbonate (CO2) Total Cobas 6000 Serum, Plasma Bilirubin, Conjugated Cobas 6000 Serum, Plasma Bilirubin, Total Cobas 6000 Serum, Plasma, Urine Calcium Cobas 6000 Serum, Plasma, Urine Chloride Cobas 6000 Serum, Plasma Cholesterol Cobas 6000 Serum Cholesterol (HDL) Cobas 6000 Serum Complement C3 Cobas 6000 Serum Complement C4 Cobas 6000 Serum, Plasma C-Reactive Protein (CRP) Cobas 6000 Serum, Plasma Creatine Kinase (CK) Cobas 6000 Page 1 of 4
3 Serum, Plasma Creatine Kinase MB (CKMB) Mass Cobas 6000 Serum, Plasma, Urine Creatinine Cobas 6000 Serum Ferritin Cobas 6000 Serum, Plasma Gamma Glutamyl Transferase (GGT) Cobas 6000 CSF, Urine, Pleural Fluid, Glucose Cobas 6000 Serum, Plasma Glucose (random/fasting) Cobas 6000 Serum Haptoglobin Cobas 6000 Whole Blood HbA1c Cobas 6000 Serum Iron Cobas 6000 Serum Kappa Freelite Cobas 6000 Serum Lambda Freelite Cobas 6000 Serum Lipase Cobas 6000 CSF, Plasma Lactate Cobas 6000 Lactate Dehydrogenase (LDH) Cobas 6000 Serum, Plasma, Urine Magnesium Cobas 6000 Urine, Stool Metabolic Screen: Reducing Substance ID TLC Urine, Stool Metabolic Screen: Reducing Substance Screen Benedict's Stool Occult Blood Manual Method / Linear Serum, Plasma, Urine Osmolality Osmometer Serum, Plasma, Urine Phosphate Cobas 6000 Serum, Plasma, Urine Potassium Cobas 6000 Serum, CSF Protein Electrophoresis Sebia Hydrasys Urine Protein Electrophoresis (Bence Jones) Manual Method-Sebia Hydrasys CSF, Urine Protein (Micro) Cobas 6000 Protein (Total) Cobas 6000 Urine Porphobilinogen (PBG) Manual Method- Spectrophotometry Serum, Plasma, Urine Sodium Cobas 6000 Serum Triglycerides Cobas 6000 Serum, Plasma, Urine Urate Cobas 6000 Serum, Plasma, Urine Urea Cobas 6000 Blood Gas: Whole Blood ph Radiometer ABL90 Flex Whole Blood PO2 Radiometer ABL90 Flex Whole Blood PCO2 Radiometer ABL90 Flex Whole Blood Ionised Calcium Radiometer ABL90 Flex Endocrinology Serum Alpha Feto-protein (AFP) Cobas 6000 Page 2 of 4
4 Serum CA 15.3 Cobas 6000 Serum CA 19.9 Cobas 6000 Serum CA 125 Cobas 6000 Serum Carcinoembryonic Antigen (CEA) Cobas 6000 Serum, Saliva Cortisol Cobas 6000 Serum Estrogen Cobas 6000 Serum Folate Cobas 6000 Serum Follicle Stimulating Hormone (FSH) Cobas 6000 Serum, Plasma Free Thyroxine (F-T4) Cobas 6000 Serum, Plasma Free Triiodothyronine (F-T3) Cobas 6000 Serum Growth Hormone Cobas 6000 Serum Human Chorionic Gonadotrophin (Quantitative) (hcg) Cobas 6000 Serum Insulin Cobas 6000 Serum Luteinising Hormone (LH) Cobas 6000 Serum Parathyroid Hormone (PTH) Intact Cobas 6000 Serum, Plasma Pro Brain Natriuretic Peptide (probnp) Cobas 6000 Serum, Plasma Procalcitonin (PCT) Cobas 6000 Serum Progesterone Cobas 6000 Serum Prolactin Cobas 6000 Serum Prostate Specific Antigen (PSA) Cobas 6000 Serum Rheumatoid Factor Cobas 6000 Serum Sex Hormone Binding Globulin (SHBG) Cobas 6000 Serum Testosterone Cobas 6000 Serum Thyroid Microsomal Antibodies (a-tpo) Cobas 6000 Serum Thyroid Stimulation Hormone Receptor Antibodies (TSHRA) Cobas 6000 Serum, Plasma Thyroid Stimulating Hormone (TSH) Cobas 6000 Serum Transferrin Cobas 6000 Serum, Plasma Troponin T Cobas 6000 Serum Vitamin B12 Cobas 6000 Serum Vitamin D, Total Cobas 6000 Serology Serum Antistreptolysin O Titre (ASOT) Cobas 6000 Serum Anti-Thyroglobulin Antibodies (a-tga) Cobas 6000 Serum Immunoglobulin A (IgA) Cobas 6000 Serum, CSF Immunoglobulin G (IgG) Cobas 6000 Serum Immunoglobulin M (IgM) Cobas 6000 Original Date of Accreditation: 04 August 2010 Page 3 of 4
5 ISSUED BY THE SOUTH AFRICAN NATIONAL ACCREDITATION SYSTEM Accreditation Manager Page 4 of 4
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